Clinical trial · Observational
Long-term Follow up Local Registry Study of Kymriah in South Korea
A Registry to Assess Long-Term Safety of Patients With B-Lymphocyte Malignancies Treated With Tisagenlecleucel in South Korea
NCT06785818CI-TRIAL-00119981recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is multicenter, primary data collection, non-interventional registry study to assess long-term safety, secondary malignancy risk, and effectiveness of tisagenlecleucel in patients with B-cell malignancies in a routine clinical practice setting in Korea.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma | B Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tisagenlecleucel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tisagenlecleucel
- description
- Patients who have been treated with tisagenlecleucel
- interventionNames
- Other: Tisagenlecleucel
Primary outcomes (3)
- measure
- The type and frequency of AEs, ADRs, SAEs, SADRs, UAEs, UADRs, USAEs, USADRs, AESI
- timeFrame
- Up to 15 years post-infusion
- description
- The type and frequency of adverse event (AE)/adverse drug reaction (ADR)/ serious adverse event (SAE)/serious adverse drug reaction (SADR)/ unexpected adverse event (UAE)/unexpected adverse drug reaction (UADR)/ unexpected serious adverse event (USAE)/unexpected serious adverse drug reaction (USADR)/ adverse event of special interest (AESI)
- measure
- Identify participants for chimeric antigen receptor (CAR) transgene detection and/or CAR surface expression (if applicable).
- timeFrame
- Up to 15 years post-infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who receive tisagenlecleucel infusion in the commercial setting, treated under a managed access program or other pathway, e.g., when product was manufactured for the commercial setting but turned out to be out of specification (OOS). 2. Consented to data collection. Exclusion Criteria: 1\. Patients who are enrolled or will be enrolled in the Novartis long term follow-up protocol CCTL019A2205B.
References
Publications (0)
Data not yet available
No reference posted for this study.